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Collaborative Multi-level Obesity Intervention Engaging Communities Trial

ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTulane University

About this trial

The goal of this clinical trial is to test the effectiveness of an evidence-based multi-level intervention for weight loss and the feasibility, fidelity, and sustainability of implementing the intervention in people living with obesity in Louisiana. The main questions it aims to answer are:

* Will an evidence-based multi-level obesity intervention (called LA-CEAL CONNECT) in Louisiana communities achieve weight loss at 6 months compared to enhanced usual care? * Will LA-CEAL CONNECT sustain weight loss at 12 months? * Will LA-CEAL CONNECT improve waist circumference, diet quality, physical activity, quality of life, and blood pressure at 6 and 12 months? * Will LA-CEAL CONNECT be feasible to implement in adults living with obesity in Louisiana communities?

Researchers will compare the LA-CEAL CONNECT multilevel weight loss intervention to enhanced usual care to evaluate if LA-CEAL CONNECT leads to greater weight loss and greater changes in waist circumference, diet, physical activity, quality of life, and blood pressure than enhanced usual care.

Participants in both arms will:

* Receive health literacy-tailored educational materials and resources for weight loss * Visit the clinic site for baseline, 6-month and 12-month study visits to collect clinical and survey measurements

Participants in the CONNECT intervention arm will also:

* receive health coaching * self-monitor weight and physical activity using digital technologies * attend group meetings to identify and increase utilization of community health and wellness resources

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

being 18 to 75 years of age

living with obesity, defined as a BMI between 30 and 50 kg/m2 for non-Asian identifying participants and BMI between 27.5 and 50 kg/m2 for Asian-identifying participants

weighing less than 400 pounds

receiving care from or willing to register at a participating FQHC clinic

Disqualifiers

having given birth within the past year, pregnant or planning to become pregnant during study period (within 1 year)

currently participating in a weight-loss program

having lost more than 10 pounds in the last 6 months

being an employee or a family member of an employee of any participating FQHC

Trial design

Design model

Parallel

Treatments tested in this trial

  • Health Literacy and Culturally Tailored Materials

    Behavioral

    Participants will receive health literacy-appropriate written information on community resources and weight management

  • Community-Engaged Health Coaching and Navigation

    Behavioral

    Participants will receive virtual coaching sessions over a 6-month period from trained Community Health Workers (CHWs). Coaching will include culturally competent information and strategies for weight management, and linking participants to community wellness resources identified in Community Asset Mapping (see below). Coaches will also remotely monitor patients' weight loss and physical activity via online portals to provide patients with tailored support during coaching sessions.

  • Self-Monitoring and Remote Patient Monitoring of weight and physical activity

    Behavioral

    Participants will self-monitor weight and physical activity during the 6-month health coaching protocol using a cellular-connected digital weight scale and a Bluetooth-connected wrist-worn fitness tracking device (e.g., Fitbit). Participants will be instructed to weigh themselves and wear a fitness tracker (e.g., Fitbit) daily. Health coaches will remotely monitor weight and physical activity data logged by these devices to incorporate into health coaching sessions.

  • Community Asset Mapping (CAM)

    Other intervention

    The CHW from each intervention community clinic will convene a team of community members, including but not limited to CONNECT participants, that will meet regularly to identify and describe community assets that enable, support, and promote healthy lifestyles related to weight loss and management (e.g., healthy eating and physical activity resources). Community teams will be supported to design and implement Community Action Projects to promote the utilization of community resources identified in the map.

  • Primary Care Provider Training

    Other intervention

    Education sessions will be provided to FQHC providers. The training curriculum is designed to increase healthcare providers' knowledge of evidence-based and guideline-concordant obesity management strategies in primary care settings.

  • Obesity Toolkit for Primary Care Providers

    Other intervention

    We will provide FQHC providers with a toolkit containing additional obesity management resources and information and the community resource guides given to participants to support obesity management.

Treatment groups

522 Participants
are divided into 2 treatment groups
Group A: LA-CEAL CONNECT InterventionExperimental treatment 6 interventions
Group B: Enhanced Usual CareActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Between-group difference in % weight change

Trained personnel will measure weight at all visits using a digital weight scale. For weight, measurement will be performed twice, with a third measurement if the first 2 measurements deviate more than 0.1 kg. An average of the two closest measurements will be used for analyses.

Time frame
6 months

Secondary outcomes

1

Between-group difference in change in waist circumference

Trained personnel will measure waist circumference at all study visits using a non-elastic tape measure placed on the skin in a horizontal plane around the abdomen at the level of the iliac crest. The measurement will be performed twice, with a third measurement if the first 2 measurements deviate more than 0.5 cm; average of the two closest measurements will be used for analyses.

Time frame
6 months
2

Between-group difference in change in blood pressure

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured at every study visit using an oscillometric Omron Professional Intellisense Blood Pressure Monitor HEM-907XL and following the American Heart Association (AHA) protocol.

Time frame
6 months
3

Between-group difference in change in dietary intake

Diet will be self-reported at every study visit using a diet screener that has been developed by the study investigators and used in past studies. The screener will assess frequency of consumption of selected food and drinks over the past month - including fruits and vegetables, high-fat foods, and alcoholic beverages.

Time frame
6 months
4

Between-group difference in change in physical activity

Physical activity will be self-reported at every study visit using the 7-item international physical activity questionnaire - short form (IPAQ-SF). This tool records the time spent at 4 different activity levels (vigorous, moderate, walking, sitting) according to 7-day recall. Scores are computed by calculating total minutes/week or total MET-minutes/week spent in the following activity levels: vigorous, moderate, walking, sitting. A total physical activity score is computed by summing the values for vigorous, moderate, and walking domains. The minimum score is 0 (no activity), with higher scores indicating more physical activity. The categorical physical activity level (low, moderate, and high) will be calculated using cut points recommended by the authors. Continuous activity score may be used as a more sensitive measure of participant physical activity change.

Time frame
6 months

Other outcomes

1

Between-group difference in % weight change

Change in weight from the baseline visit to the 12 month visit using a standard protocol (see above).

Time frame
12 months
2

Between-group difference in change in waist circumference

Change in waist circumference from the baseline visit to the 12 month visit using a standard protocol (see above).

Time frame
12 months
3

Between-group difference in change in blood pressure

Change in SBP and DBP from baseline visit to 12 month visit using a standard protocol (see above).

Time frame
12 months
4

Between-group difference in change in dietary intake

Diet will be self-reported at every study visit using a diet screener that has been developed by the study investigators and used in past studies. The screener will assess frequency of consumption of selected food and drinks over the past month - including fruits and vegetables, high-fat foods, and alcoholic beverages.

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tulane University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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